The DIagnostic VAlue of Musculoskeletal UltraSound (MSUS) in the detection of Early signs ofpsoriatic arthritis - An open label, proof-of-concept study using Apremilast in a cohort of very earlypsoriatic arthritis in patients with ultrasound-enthesitis and arthralgia (The DIVAMUSE-study) - DIVAMUSE

niversitätsklinikum Freiburg0 sites30 target enrollmentApril 27, 2022

ConditionsEnthesitis M07.0 M07.3 Distal interphalangeal psoriatic arthropathy Other psoriatic arthropathies

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Enthesitis
Sponsor: niversitätsklinikum Freiburg
Enrollment: 30
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 27, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversitätsklinikum Freiburg

Eligibility Criteria

Inclusion Criteria

•1\. Male or female, age \= 18 years.
•2\. The diagnosis of psoriatic arthritis should be confirmed during and/or fulfilled at screening according to CASPAR classification criteria. Family history of psoriasis and/or personal history of dactylitis is not mandatory, but can be used in order to fulfill CASPAR classification criteria.
•3\. If the diagnosis of psoriatic arthritis as per CASPAR classification criteria is already fulfilled, diagnosis should be not older than 6 months, and the patients should have had an inadequate response or have been intolerant to a prior DMARD therapy (not more than two doses shall have been received). NSAIDs and fumaric acid as prior treatments are allowed.
•4\. Musculoskeletal symptom duration should not be longer than 12 months before screening.
•5\. Plaque psoriasis (history of and/or active disease) as confirmed by a dermatologist (biopsy encouraged, but not mandatory).
•6\. Nail psoriasis confirmed by a dermatologist; in doubtful cases, fungal infection should be ruled out. Active disease in at least one finger or toenail at both screening and baseline is required.
•7\. Presence of arthralgia (mechanical reason should be ruled out).
•8\. Active enthesitis confirmed by MSUS, and prevalent at both screening and baseline.
•9\. Negative for rheumatoid factor AND ACPA; ANA within normal range.
•10\. If patients are on NSAIDs, a stable dose shall be kept during 2 weeks before baseline. Moreover, patients are encouraged to maintain a stable NSAID\-dose during the course of the study; in the case of a flare however, NSAIDS can be used as a rescue medication (please see section on rescue medication for details).

Exclusion Criteria

•1\.Unwillingness or incapacity of adherence to study protocol
•2\.Musculoskeletal symptom duration \> 12 months before screening
•3\.Pregnant or breastfeeding WOCBP, or women that plan to become pregnant during the course of the study or up to 3 months thereafter; women or men unwilling to use adequate methods of contraception such as (but not limited to) hormonal implants or hormonal contraceptives.
•4\.Positivity of rheumatoid factor, or ACPA or elevated concentration of ANA.
•5\.Iritis / anterior uveitis currently or in the last 6 months before first dose of study drug.
•6\.Any joint or enthesial infiltration or operation during \< 12 weeks before baseline or during the course of the study.
•7\.New NSAID initiated or dose change \= 2 weeks before baseline.
•8\.Changes in dose of glucocorticosteroids or dosage \> 10mg/d \= 2 weeks before baseline.
•9\.Pre\-treatment of psoriatic arthritis with PDE\-4\-inhibitors, JAK\-inhibitors, or any fusion proteins, or biological or conventional DMARDs other than methotrexate.
•10\.Use of any investigational drug other than study medication.